Apply on Employer Site

Catalent · 1 week ago

Associate Director Quality Assurance

Philadelphia, PA

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to developing and supplying products for better health. The Associate Director, Quality Assurance is responsible for providing leadership and support for Quality Assurance activities at the Philadelphia site, ensuring compliance with cGMP guidelines and managing QA teams for clinical and commercial manufacturing operations.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Quality liaison for clients and internal customers; is expected to become the owner or escalation point for client requests/issues

Accountable for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus

Participate in Regulatory Inspections and Customer Audits, etc

Participate in site and customer meetings/communications and be directly involved in critical projects/issues

Establishes goals and monitors performance through monthly, quarterly, and annual summaries and metrics

Present summary data to site management on a regularly scheduled basis

Provide QA Technical recommendations based on trend analysis to eliminate future problems

Participates in project meetings to provide input with respect to compliance to cGMP requirements

Other duties as assigned

Qualification

CGMP regulationsPharmaceutical industry experienceLeadership experienceRegulatory agency interactionContract manufacturing experienceQuality control experienceScientific degreeSoft skills

Required

Bachelor's degree in scientific discipline, chemistry, biochemistry, biology, microbiology, or chemical engineering, required

Minimum of 10 years' relevant experience in the pharmaceutical industry

Minimum four years of leadership/management experience with demonstrated ability to set vision and direction for a team including setting expectations and motivating for results to achieve corporate, site and departmental objectives

Working knowledge of cGMPs regulations, required; prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)

Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Preferred

Experience working with customers – Contract manufacturing experience, preferred

Prior experience working with quality control, or GMP manufacturing/packaging, preferred

Prior experience working directly with regulatory agencies and handling inspections, preferred

Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience

Benefits

152 hours of PTO + 8 paid holidays

Generous 401K match

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement

WellHub - program to promote overall physical wellness

Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees

https://www.catalent.com

H1B Sponsorship

Catalent has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2022 (1)